Esophageal CancerNCT04217239
A Comparison Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy
A study testing MIE Ivor- Lewis and MIE McKeown in people with Esophageal Cancer, run by The Second Hospital of Shandong University at 1 site in China.
Trial summary
Surgery is still the main treatment for esophageal cancer, however, the complication and mortality rate of open esophagectomy is high. As a result, the thoracoscopic- laparoscopic minimally invasive esophagectomy (MIE) was developed. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- MIE Ivor- Lewis and MIE McKeown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinically staged T1-3N0-2M0 tumors; good cardiopulmonary function;
- Patients with lower thoracic esophageal tumors and esophageal- gastric junction tumor;
- Patients without a previous history of cancer;
- Patients without a previous history of neck or chest surgery;
Who cannot join
- cardiopulmonary function not good enough for surgery;
- Patients with hybrid MIE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Short-term and Long- Term Outcomes Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy
Surgery is still the main treatment for esophageal cancer, however, the complication and mortality rate of open esophagectomy is high. As a result, the thoracoscopic- laparoscopic minimally invasive esophagectomy (MIE) was developed. The MIE mainly comprised two surgical approaches:
MIE McKeown approach (cervical anastomosis) and MIE Ivor-Lewis approach (intrathoracicanastomosis). The MIE with intrathoracic anastomosis (Ivor-Lewis) is increasingly used for the treatment of mid and lower esophageal cancers. Our study is trying to compare the safety, feasibility, and short-term and long- term outcomes between MIE Ivor-Lewis approach and MIE McKeown approach for the treatment of lower thoracic esophageal cancer and esophageal- gastric junction.
- Conditions
- Esophageal Cancer
- Being tested
- MIE Ivor- Lewis, MIE McKeown
- Keywords
- Thoracoscopic, laparoscopic, esophagectomy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIE Ivor- LewisProcedure or surgery
minimally invasive esophagectomy (MIE) with intrathoracic anastomosis
MIE McKeownProcedure or surgery
minimally invasive esophagectomy (MIE) with cervical anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Ivor-Lewis group | Experimental | minimally invasive esophagectomy (MIE) with intrathoracic anastomosis Receives: Procedure: MIE Ivor- Lewis |
| McKeown group | Active comparator | minimally invasive esophagectomy (MIE) with cervical anastomosis Receives: Procedure: MIE McKeown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall postoperative complications
Overall postoperative complication rates
Measured: within one month
Secondary outcomes (13)
Operating time
Operating time in minutes
Measured: 1 day
Lymph nodes harvested
Lymph nodes harvested in number
Measured: 1 day
Blood loss
Blood loss in milliliter
Measured: 1 day
Anastomotic leak
Anastomotic leak in rate
Measured: within one month
Pulmonary complication
Pulmonary complication in rate
Measured: 1 month
Anastomotic stenosis
Anastomotic stenosis in rate
Measured: within three months
recurrent laryngeal nerve injury
recurrent laryngeal nerve injury in rate
Measured: within three months
Chylothorax
Chylothorax in rate
Measured: within one month
Cardiac arrhythmia
Cardiac arrhythmia in rate
Measured: within one month
Laboratory findings
Three-day postoperative laboratory findings including ALB, PA, Glob, etc.
Measured: within 3 days
Hospital stay
Hospital stay in days
Measured: within 60 days
mortality
mortality in rate
Measured: within 30 and 90 days
progression-free survival
progression-free survival in rate
Measured: within 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start1 Jan 2020
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217239
- Sponsor's protocol ID
- MIE ZYP2
- Status last verified
- Feb 2026
- First submitted
- 1 Jan 2020
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao Y, Shan L, Peng C, Cong B, Zhao X. Learning curve for minimally invasive oesophagectomy of oesophageal cancer and survival analysis. J Cardiothorac Surg. 2021 Nov 10;16(1):328. doi: 10.1186/s13019-021-01712-7.
PubMed 34758861
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Short-term and Long- Term Outcomes Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy
- ClinicalTrials.gov ID
- NCT04217239
- Acronym / sponsor ID
- MIE ZYP2
- Conditions
- Esophageal Cancer
- Keywords
- Thoracoscopic, laparoscopic, esophagectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgery is still the main treatment for esophageal cancer, however, the complication and mortality rate of open esophagectomy is high. As a result, the thoracoscopic- laparoscopic minimally invasive esophagectomy (MIE) was developed. The MIE mainly comprised two surgical approaches:
MIE McKeown approach (cervical anastomosis) and MIE Ivor-Lewis approach (intrathoracicanastomosis). The MIE with intrathoracic anastomosis (Ivor-Lewis) is increasingly used for the treatment of mid and lower esophageal cancers. Our study is trying to compare the safety, feasibility, and short-term and long- term outcomes between MIE Ivor-Lewis approach and MIE McKeown approach for the treatment of lower thoracic esophageal cancer and esophageal- gastric junction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivor-Lewis group | Experimental | Procedure: MIE Ivor- Lewisminimally invasive esophagectomy (MIE) with intrathoracic anastomosis |
| McKeown group | Active comparator | Procedure: MIE McKeownminimally invasive esophagectomy (MIE) with cervical anastomosis |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with clinically staged T1-3N0-2M0 tumors; good cardiopulmonary function;
- Patients with lower thoracic esophageal tumors and esophageal- gastric junction tumor;
- Patients without a previous history of cancer;
- Patients without a previous history of neck or chest surgery;
Key exclusion criteria (2 listed)
- cardiopulmonary function not good enough for surgery;
- Patients with hybrid MIE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIE Ivor- Lewisminimally invasive esophagectomy (MIE) with intrathoracic anastomosis | Procedure or surgery | Ivor-Lewis group |
| MIE McKeownminimally invasive esophagectomy (MIE) with cervical anastomosis | Procedure or surgery | McKeown group |
Primary outcome
Overall postoperative complications
Time frame: within one month
Overall postoperative complication rates
13 secondary outcomes
Operating time
Time frame: 1 day
Lymph nodes harvested
Time frame: 1 day
Blood loss
Time frame: 1 day
Anastomotic leak
Time frame: within one month
Pulmonary complication
Time frame: 1 month
Anastomotic stenosis
Time frame: within three months
recurrent laryngeal nerve injury
Time frame: within three months
Chylothorax
Time frame: within one month
Cardiac arrhythmia
Time frame: within one month
Laboratory findings
Time frame: within 3 days
Hospital stay
Time frame: within 60 days
mortality
Time frame: within 30 and 90 days
progression-free survival
Time frame: within 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Derived from this study: PubMed 34758861Zhao Y, Shan L, Peng C, Cong B, Zhao X. Learning curve for minimally invasive oesophagectomy of oesophageal cancer and survival analysis. J Cardiothorac Surg. 2021 Nov 10;16(1):328. doi: 10.1186/s13019-021-01712-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIE Ivor- Lewis and MIE McKeown in people with Esophageal Cancer, run by The Second Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall postoperative complications (time frame: within one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04217239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.